BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AMBULATORY INFUSION PUMP DRUG RESERVOIR

    K Number: K870524 · Decision May 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    22
    Review Days
    89

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    Basic Information

    Device Name
    AMBULATORY INFUSION PUMP DRUG RESERVOIR
    K Number
    K870524
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Med Fusion Systems, Inc.
    Date Received
    February 6, 1987
    Decision Date
    May 6, 1987
    Product Code
    FRN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRN Pump, Infusion

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    Other Clearances by Med Fusion Systems, Inc.

    K Number Device Name
    K873961 INFUMED 300 AMBULATORY INFUSION PUMP
    K870907 INTRODUCER, PERCUTANEOUS
    K864407 REFILLABLE SYRINGE
    K863814 BAG SPIKE EXTENSION SET
    K860616 VOLUME CONTROL SET WITH EXTENSION
    K860803 IV FILTER EXTENSION SET
    K844313 INFUSET W/HUBER NEEDLE
    K842984 EXTENSION SET W/INJECTION SITE
    K842143 BENT WINGED MINI-VOL INFUSION SET
    K841882 THREE WAY INFUSION SET
    Search all 22 clearances from Med Fusion Systems, Inc. →